Human research is research conducted with or about people, or their data or tissue.
The appropriate review pathway for your human research project depends on the level of risk and for multisite ethical review the number and location of sites included for review.
Level of Risk
Risk is defined as a potential for harm, discomfort or inconvenience. It involves the likelihood that a harm (or discomfort or inconvenience) will occur and the severity of the harm, including its consequences. The risk may be to participants and/or to others e.g. family members, social group. Both the type of risk and the level of risk must be considered. The types of risks are well described in the National Statement on Ethical Conduct in Human Research (see Chapter 2.1, page 12).
Research with more than a low level of risk must be reviewed by the full Ethics Committee, for example, any research involving an intervention or requiring tissue/blood samples; research that could raise difficult/sensitive issues for participants and/or others; research requiring tissue or data to be sent offsite. Research with a low level of risk, for example prospective research projects involving surveys or questionnaires and research projects using existing data collections, may be reviewed by other pathways.
Multisite Ethical Review - Number and Location of Sites
The Peter MacCallum Cancer Centre Ethics Committee can provide ethical review for clinical trials and other human health and medical research projects, including low risk and negligible risk research projects, for multiple sites in Victoria, New South Wales, Queensland, South Australia, Australian Capital Territory and Western Australia. IMPORTANT NOTE: New South Wales and South Australia do not accept ethical review of Phase I clinical trials.
All research being ethically reviewed for sites outside of Victoria must be submitted and reviewed by the full Ethics Committee, regardless of the risk level of the project. Research being ethically reviewed for multiple sites only in Victoria may be reviewed by the full Ethics Committee or by other pathways, as appropriate to the risk level of the project.
Multisite Ethical Review – Investigator Responsibilities
For multisite ethical review submissions the Coordinating Principal Investigator (CPI) is responsible for submitting the Ethics application on behalf of all participating sites. The Ethical Approval will be issued to the Coordinating Principal Investigator and list all eligible sites included in the ethics application. Reports required for ongoing ethical monitoring of the project for all sites e.g. amendments and annual reports, must be submitted to the reviewing HREC by the CPI or project sponsor on behalf of all sites.
Each participating site is still responsible for providing authorisation for a new project to commence at that site and for an amended project to continue at that site. The Principal Investigator (PI) at each site is responsible for submitting a governance application to the site Research Governance Office to obtain site authorisation to commence or continue. Principal Investigators will need to consult their local Research Governance Office for submission advice.
Ethical review pathways summary
- Peter Mac Human Research Ethics Committee providing Ethical Review
- Low and negligible Risk Research
- Retrospective Research
NOTE: Fees will change from 1 July 2019 – please consult the new fee schedule.
See Submission Dates and Submission Fees for current fee schedule.
See Submission Dates and Submission Fees for upcoming submission dates for ethical review meetings.
APPLICATION FOR GOVERNANCE REVIEW AT PETER MAC
Governance review is also required for projects to be undertaken at Peter Mac. For detailed information about the requirements for a Peter Mac Governance Review application, please refer to Governance Review.
Email: [email protected]
Phone: 03 8559 7540